Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with FARXIGA. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with FARXIGA even if your blood sugar is less than 250 mg/dL. Stop taking FARXIGA and call your healthcare provider right away if you get any of the following symptoms:

nausea

vomiting

stomach area (abdominal) pain

tiredness

trouble breathing

If you get any of these symptoms during treatment with FARXIGA, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.

reduce the amount of food or liquid you drink, for example, if you are sick and cannot eat or

you start to lose liquids from your body, for example, from vomiting, diarrhea or being in the sun too long.

Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking FARXIGA. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting

Low blood sugar (hypoglycemia). If you take FARXIGA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take FARXIGA. Signs and symptoms of low blood sugar may include:

headache

shaking or feeling jittery

irritability

fast heartbeat

weakness

drowsiness

sweating

confusion

dizziness

hunger

A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take FARXIGA. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:

pain or tenderness

swelling

redness of skin (erythema)

The most common side effects of FARXIGA include:

vaginal yeast infections and yeast infections of the penis

stuffy or runny nose and sore throat

changes in urination, including urgent need to urinate more often, in larger amounts, or at night

These are not all the possible side effects of FARXIGA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The most common side effects of FARXIGA include:

Vaginal yeast infections and yeast infections of the penis

Stuffy or runny nose and sore throat

Changes in urination, including urgent need to urinate more often, in larger amounts, or at night

These are not all the possible side effects of FARXIGA. For more information, please read the Medication Guide; ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca products by clicking here.

Important Safety Information

Who should not take FARXIGA?

Do not take FARXIGA if you:

are allergic to dapagliflozin or any of the ingredients in FARXIGA. Symptoms of a serious allergic reaction may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking FARXIGA and contact your healthcare provider or go to the nearest hospital emergency room right away

have severe kidney problems and are taking FARXIGA to lower your blood sugar

are on dialysis

What are the possible side effects of FARXIGA?

FARXIGA may cause serious side effects including:

Dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with type 2 diabetes who are taking FARXIGA. You may be at a higher risk of dehydration if you take medicines to lower your blood pressure, including water pills (diuretics); are age 65 or older; are on a low salt diet, or have kidney problems. Talk to your doctor about what you can do to prevent dehydration including how much fluid you should drink on a daily basis

Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with FARXIGA. Ketoacidosis is a serious condition which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal pain. If you get any of these symptoms, stop taking FARXIGA and call your healthcare provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL

Serious urinary tract infections (UTI), some that lead to hospitalization, occurred in people taking FARXIGA. Tell your healthcare provider if you have any signs or symptoms of UTI including a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine with or without fever, back pain, nausea, or vomiting

Low blood sugar (hypoglycemia) can occur if you take FARXIGA with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include shaking, sweating, fast heartbeat, dizziness, hunger, headache, and irritability. Follow your healthcare provider's instructions for treating low blood sugar

Bacterial infections under the skin of the genitals and areas around them. Rare but serious infections that cause severe tissue damage under the skin of the genitals and areas around them have happened with FARXIGA. This infection has happened in women and men and may lead to hospitalization, surgeries and death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable and you also develop any pain or tenderness, swelling, or redness of the skin in the genitals and areas around them

Vaginal yeast infections in women who take FARXIGA. Talk to your healthcare provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching

Yeast infection of skin around the penis (balanitis) in men who take FARXIGA. Talk to your healthcare provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around penis. Certain uncircumcised men may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis

The most common side effects of FARXIGA include yeast infections of the vagina or penis, and changes in urination, including urgent need to urinate more often, in larger amounts, or at night.

What should I tell my healthcare provider before taking FARXIGA?

Before you take FARXIGA, tell your healthcare provider:

all of your medical conditions, including problems with your kidneys, liver, bladder, or pancreas

if you have had, or have risk factors for, ketoacidosis (including type 1 diabetes, are eating less due to illness, surgery, or a change in your diet, are going to have surgery, or binge drink)

if you are pregnant, or plan to become pregnant. FARXIGA may harm your unborn baby

if you are breastfeeding, or plan to breastfeed. It is unknown if FARXIGA passes into your breast milk

about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements

What is FARXIGA?

FARXIGA is a prescription medicine used to:

improve blood sugar control along with diet and exercise in adults with type 2 diabetes

reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors

reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (when the heart is weak and cannot pump enough blood to the rest of your body)

FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

You may report side effects related to AstraZeneca products byclicking here.

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